NEUROSURGICAL
Rethinking Possibilities, Reshaping Lives
SURGICAL TECHNIQUE GUIDE
TABLE OF CONTENTS
Introduction 3
Preoperative Planning 5
Manual Spring Implantation 6
Inserter Spring Implantation 10
Spring Removal Guide 15
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SPRING ASSISTED SURGERY FOR THE TREATMENT OF CRANIOSYNOSTOSIS
IntroductionSmartFlex offers early minimally invasive surgical intervention to decrease the morbidity associated with an extensive decompression operation.
SMARTFLEX SPRING CLIP
Foot Plate• Beveled to reduce the possibility of dural tear• Designed to fit securely under the skull bone
Spring SleeveSecures the springs during implantation.
SmartFlex Cranial Spring• Pre-formed to match curvature of infant skull• Medical grade stainless steel
Spring ClipLow profile, ergonomic design to a minimally invasive surgical approach.
Push-Button AttachmentSecures the spring clip to the spring inserter instrument.
DO NOT USE IF PACKAGE IS DAMAGED
ATTENTION: SEE INSTRUCTIONS FOR USE
CAUTION:CONSULT ACCOMPANYING
DOCUMENTS
SINGLE USE ONLY CONSULT INSTRUCTIONSFOR USE
USED BY DATE
TEMPERATURE MANUFACTURER DATE OF MANUFACTURERFEDERAL LAW (U.S.A.)
RESTRICTS THE DEVICE TOSALE BY OR ON THE ORDER OF
A PHYSICIAN
STERILE, METHOD OF STERILIZATION USING
IRRADIATION
ONLY
STERILE R
SMARTFLEX CRANIAL SPRING
Foot Plate• Beveled to reduce the possibility of dural tear• Designed to fit securely under the skull bone
Cranial Spring• Pre-formed based on an extensive analysis of infant skulls• Medical grade stainless steel• Adjustable to accommodate various skull anatomies
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SMARTFLEX INSERTER
Spring Loaded Trigger
Ergonomic HandleFor comfort and ease of use.
Push-Button FeatureSecures the spring clip to the spring inserter instrument.
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PREOPERATIVE PLANNING
Evaluate Initial 3-D CT scan
• Determine characteristics of skull shape.• Rule out intracranial abnormalities.
Utilize the 3D model or CT scan to plan spring placement.• Identify type of scaphocephaly, bone thickness and assess underlying pathology.• Contour the springs to accommodate the skull anatomy.
Note: Excessive contouring may compromise the force of the spring.
Utilize the table below to determine spring force. Force is based on age, bone thickness, and severity of the deformity.
Note: The 4N and 4.5N cranial springs are available for rare malformations such as a cloverleaf skull deformity.
ANTERIOR SPRING SELECTION
Patient Age (Months)Type of Deformity
3 to 4 Mild 6N 6N 6.5N
6N 6N 6.5-7N
6.5N 6.5N 6.5-7N
6.5N 6.5N 7N
6.5N 7N 7.5N
6.5N 7N 7.5-8N
3 to 4 Moderate
3 to 4 Severe
5 to 6 Mild
5 to 6 Medium
5 to 6 Severe
Bo
ne
Th
ickn
ess
<2m
m
Bo
ne
Th
ickn
ess
2mm
to
5m
m
Bo
ne
Th
ickn
ess
>5m
m
POSTERIOR SPRING SELECTION
Patient Age (Months)Type of Deformity
3 to 4 Mild 6.5N 6.5N 6.5N
6.5N 6.5N 6.5N
6.5N 7N 7N
7N 7N 7.5N
7N 7.5N 7.5-8N
7N 7-8N 8-8.5N
3 to 4 Medium
3 to 4 Severe
5 to 6 Mild
5 to 6 Medium
5 to 6 Severe
Bo
ne
Th
ickn
ess
<2m
m
Bo
ne
Th
ickn
ess
2mm
to
5m
m
Bo
ne
Th
ickn
ess
>5m
m
ANTERIOR SPRING SELECTION
Patient Age (Months)Type of Deformity
3 to 4 Mild 6N 6N 6.5N
6N 6N 6.5-7N
6.5N 6.5N 6.5-7N
6.5N 6.5N 7N
6.5N 7N 7.5N
6.5N 7N 7.5-8N
3 to 4 Moderate
3 to 4 Severe
5 to 6 Mild
5 to 6 Medium
5 to 6 Severe
Bo
ne
Th
ickn
ess
<2m
m
Bo
ne
Th
ickn
ess
2mm
to
5m
m
Bo
ne
Th
ickn
ess
>5m
m
POSTERIOR SPRING SELECTION
Patient Age (Months)Type of Deformity
3 to 4 Mild 6.5N 6.5N 6.5N
6.5N 6.5N 6.5N
6.5N 7N 7N
7N 7N 7.5N
7N 7.5N 7.5-8N
7N 7-8N 8-8.5N
3 to 4 Medium
3 to 4 Severe
5 to 6 Mild
5 to 6 Medium
5 to 6 Severe
Bo
ne
Th
ickn
ess
<2m
m
Bo
ne
Th
ickn
ess
2mm
to
5m
m
Bo
ne
Th
ickn
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>5m
m
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MANUAL SPRING IMPLANTATION
Step 1
Design incisions on the anterior and posterior fontanel approximately 4 cm in width.
Step 2
Inject local (.25% marcaine with epinephrine) at incision site and over the area of the fused suture.
Step 3
Make the incision with a 15 blade in the direction of the hair follicles to preserve them.
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DISTRACTOR IMPLANTATION
Step 4
Lift the scalp in the subgaleal plane under direct vision from the incision to the anterior and poste-rior limit of the suture.
Step 5
Remove 1 cm of the fused suture throughout entire length with the help of the endoscope and bone cutters.
FUSED SUTURE
Step 6
Obtain hemostasis at the bone margin and the dura.
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DISTRACTOR IMPLANTATION
Step 7
Select the spring force based on guide that considers age, bone thickness, and severity of the deformity.
If necessary, bend the spring using the supplied bending instrument to accomodate patient’s anatomy.
Note: Off plane bending and excessive bending may compromise the spring force.
Step 8
Place the springs and confirm positioning.
Note: Ensure foot plate hooks are positioned firmly on the cranial bone.
Note: To prevent spring migration, the spring leap shall be placed parallel to the suture line.
Step 9
Secure the springs to the bone where they overlap with a 4-0 vicryl suture by drilling a hole in the bone lateral to where the springs overlap. (Should be done on both sides)
ANTERIOR SPRING SELECTION
Patient Age (Months)Type of Deformity
3 to 4 Mild 6N 6N 6.5N
6N 6N 6.5-7N
6.5N 6.5N 6.5-7N
6.5N 6.5N 7N
6.5N 7N 7.5N
6.5N 7N 7.5-8N
3 to 4 Moderate
3 to 4 Severe
5 to 6 Mild
5 to 6 Medium
5 to 6 Severe
Bo
ne
Th
ickn
ess
<2m
m
Bo
ne
Th
ickn
ess
2mm
to
5m
m
Bo
ne
Th
ickn
ess
>5m
m
POSTERIOR SPRING SELECTION
Patient Age (Months)Type of Deformity
3 to 4 Mild 6.5N 6.5N 6.5N
6.5N 6.5N 6.5N
6.5N 7N 7N
7N 7N 7.5N
7N 7.5N 7.5-8N
7N 7-8N 8-8.5N
3 to 4 Medium
3 to 4 Severe
5 to 6 Mild
5 to 6 Medium
5 to 6 Severe
Bo
ne
Th
ickn
ess
<2m
m
Bo
ne
Th
ickn
ess
2mm
to
5m
m
Bo
ne
Th
ickn
ess
>5m
m
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Step 10
Close the incisions with a 2 layer subcutaneous and a subcuticular closure of absorbable sutures.
Step 11
Place a head wrap to protect the incisions.
DISTRACTOR IMPLANTATION
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INSERTER SPRING IMPLANTATION
Step 1
Design a “W” shape incision in between the anterior and posterior fontanel approximately 4 cm in width.
Step 2
Inject local (.25% marcaine with epinephrine) at incision site and over the area of the fused suture.
Step 3
Make the incision with a 15 blade in the direction of the hair follicles to preserve them.
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DISTRACTOR IMPLANTATION
Step 4
Lift the scalp in the subgaleal plane under direct vision from the incision to the anterior and poste-rior limit of the suture.
Step 5
Using a Neuro Rongeur, remove 1 cm of the fused suture throughout entire length with the help of the endoscope.
FUSED SUTURE
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DISTRACTOR IMPLANTATION
Step 7
Select the spring force based on guide that considers age, bone thickness, and severity of the deformity.
Refer to page 5.
Note: The 4N and 4.5N cranial springs are available for rare malformations such as a cloverleaf skull deformity.
ANTERIOR SPRING SELECTION
Patient Age (Months)Type of Deformity
3 to 4 Mild 6N 6N 6.5N
6N 6N 6.5-7N
6.5N 6.5N 6.5-7N
6.5N 6.5N 7N
6.5N 7N 7.5N
6.5N 7N 7.5-8N
3 to 4 Moderate
3 to 4 Severe
5 to 6 Mild
5 to 6 Medium
5 to 6 Severe
Bo
ne
Th
ickn
ess
<2m
m
Bo
ne
Th
ickn
ess
2mm
to
5m
m
Bo
ne
Th
ickn
ess
>5m
m
POSTERIOR SPRING SELECTION
Patient Age (Months)Type of Deformity
3 to 4 Mild 6.5N 6.5N 6.5N
6.5N 6.5N 6.5N
6.5N 7N 7N
7N 7N 7.5N
7N 7.5N 7.5-8N
7N 7-8N 8-8.5N
3 to 4 Medium
3 to 4 Severe
5 to 6 Mild
5 to 6 Medium
5 to 6 Severe
Bo
ne
Th
ickn
ess
<2m
m
Bo
ne
Th
ickn
ess
2mm
to
5m
m
Bo
ne
Th
ickn
ess
>5m
m
Step 6
Obtain hemostasis at the bone margin and the dura.
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Step 8
Remove the spring clip assembly from the packaging. If necessary, bend the spring using the supplied bending instrument PN: 220-0024 to accommodate patient’s anatomy.
Note: Off-plane bending and excessive bending may compromise the spring force.
a. Place the spring inside the clip.
Step 9
Assemble the smartflex Spring PN: 218-30XX-SP to the smartflex Spring Inserter Instrument PN: 220-0771-SP.
Assembly Instructions
a. Insert the spring (218-30XX-SP) into the inserter until the blue tab locks into place.
b. Compress the trigger until you hear an audible click, then release the trigger.
c. Remove the security clip located on the underside of the spring clip assembly.
d. Pull the shaft of the inserter forward, retracting the arms into the spring clip assembly.
e. Make sure the spring is in the closed position.
trigger
DISTRACTOR IMPLANTATION
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Step 12
Close the incisions with a 2 layer subcutaneous and a subcuticular closure of absorbable sutures.
Place a head wrap to protect the incisions.Wound care should be routinely done.
Step 11
Secure the springs to the bone where they overlap with a 4-0 vicryl suture by drilling a hole in the bone lateral to where the springs overlap. (Should be done on both sides)
DISTRACTOR IMPLANTATION
Step 10
Insert the assembled inserter instrument under the incision. Completely compress the trigger to release the spring in desired location.
Note: Ensure foot plates are positioned firmly on the cranial bone.
Note: To prevent spring migration, the spring legs shall be placed parallel to the suture line.
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SPRING REMOVAL GUIDE
Step 1
Palpate the springs at their overlap and bony insertion points.
Step 2
Design a small incision over each of the 4 foot-plates and mark the portion of the previous inci-sion that will be utilized.
Step 3
Inject local into the 5 incisions.
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SPRING REMOVAL GUIDE
Step 4
Make each of the footplate incisions and expose the spring footplate.
Step 5
Use a Dingman elevator to free the soft tissue around the footplates and separate it from the bone.
Step 6
Use a needle driver to rotate the footplate away from the bone in the direction opposite of the initial osteotomy.
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Step 7
Repeat 5 and 6 for each of the 4 footplate sites.
Step 8
Open the portion of the previous incisions to ex-pose where the springs overlap in the midline.
Step 9
Cut the wire at the apex of the spring on each side.
SPRING REMOVAL GUIDE
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Step 10
Pull the segments of spring out of their respective incisions.
Step 11
Close the incisions with a buried and subcuticular layer of absorbable suture.
Step 12
Apply antibiotic ointment to each of the incisions, no head wrap is required.
Discard all devices according to standard biohaz-ard disposal procedures.
SPRING REMOVAL GUIDE
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1. How is bleeding controlled around the bone edges after performing the craniectomy?
The bleeding may be controlled through a combination of methods:• Utilize a bovie and protect the brain tissue with insulated malleable.• Hemosorb and/or bone wax.• Injection of Floseal in osteotomy site.
2. Can we reuse the inserter instrument on other procedures?
No. Cleaning and autoclaving may compromise the integrity of the instrument. To assure efficacy, the instrument was designed to be used in a single procedure.
3. Can we remove the springs from the clip and implant them by hand?
Yes.
FREQUENTLY ASKED QUESTIONS
OSTEOMED3885 Arapaho Rd.
Addison, TX 75001Customer Service: 800.456.7779
Customer Service Fax: 800.390.2620
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P/N 030-1781 Rev.A